OCTIMET. Company Profile

Transcription

1 OCTIMET Oncology NV (OCTIMET) is a privately held Belgian based life science company specialized in accelerating the development of oncology therapies by providing rapid clinical proof of concept through pharmacodynamic biomarker-based strategies and innovative clinical development strategies. The company is currently developing a family of selective MET kinase inhibitors, with the lead agent undergoing Phase I/II trials. The goal for the current and future development programs is to provide differentiation both within the current cancer treatment paradigms and from competitor agents using innovative trial designs and biomarker defined intelligent patient selection. In 2016 OCTIMET were accepted as one of the first tenants to take residence at the JLINX facility in Beerse that is managed by Bioqube Ventures. Cross-fertilization and organic exchange of knowledge with oncology experts and multi-disciplinary life science entrepreneurs within the JLINX community fuel a new model of scientific collaboration offering OCTIMET faster access to expertise and cross-sector insights. Tim Perera CEO OCTIMET

2 Background OCTIMET was founded in 2016 by Timothy Perera PhD, Ann Meulemans PhD, Paolo Comoglio, MD, PhD and Philip Owen. Timothy Perera, a former Janssen Oncology Discovery scientist, developed the initial pitch deck and business plan for OCTIMET Oncology during a boot camp 2014 at the Janssen Beerse campus. OCTIMET also obtained an initial feasibility grant and a subsequent O&O grant from Flanders Innovation & Entrepreneurship (VLAIO) as well as seed funding from the VIB (Vlaams Instituut voor Biotechnologie), including a collaboration with Prof. Massimiliano Mazzone at the Center for Cancer Biology (KU Leuven). OCTIMET licensed highly selective MET kinase inhibitors with clean safety profiles from Janssen Pharmaceutica and started to advance the development of these molecules with the founding OCTIMET team. Early 2017, OCTIMET secured EUR 11.3 million in a Series A investment round, led by V-Bio Ventures (Belgium) and Fund+ (Belgium), and supported by an investment syndicate including DROIA Oncology Ventures (Luxembourg/ Belgium) and OMNES Capital (France). Technology The MET oncogene activated signaling pathway is known to be hyper-activated in identifiable subsets of a range of major cancer types. The MET receptor has recently been demonstrated to be a functional marker of cancer stem like cells that are responsible for the development of resistance to radiotherapy and a number of chemotherapy and targeted anti-cancer agents. Inhibition of the MET kinase signaling pathway has been demonstrated to block MET driven cancers and overcome MET induced resistance to a range of therapeutic agents leading, in some cases, to the cure of tumor bearing preclinical animals. OCTIMET has proprietary knowledge of pathways and targets that would result in rational combination therapeutic partners. For the new cutting-edge study design, the more rational patient selection methodology and improved molecule selectivity and unique pharmacokinetics, OCTIMET has meticulously taken onboard the learnings of previous clinical studies and partnered up with UK based Simbec- Orion (study design and patient recruitment) and California based Guardant Health inc. (circulating tumour DNA based biomarker technology). 2

3 OCTIMET Pipeline-Products OCTIMET s pipeline currently focuses on advancing the development of two highly selective MET kinase inhibitors licensed from Janssen Pharmaceutica: Top-line results of this international adaptive study - 50 adult patients with a diagnosis of advanced, unresectable or metastatic solid malignancies are expected in Q OMO-1 In parallel preclinical studies are ongoing to further optimize the clinical strategy and to fine-tune the biomarker strategy. OMO-1 is a highly selective small molecule MET kinase inhibitor that has demonstrable single agent cellular and in vivo activity only in MET driven preclinical models as expected from a highly selective agent. Once predicted pharmacologically active doses are shown to be safe, MET biomarker selected populations will be recruited to generate proof of concept data to support a larger registration trial. Before licensing OMO-1 to OCTIMET, Janssen Pharmaceutica carried out a healthy volunteer trial where predicted efficacious exposures were reached without any significant adverse events. OMO-2 The clean safety and tolerability profile observed in the healthy volunteer trial is being confirmed in an accelerated Phase I dose escalation study carried out in non-selected cancer patients followed by demonstrating evidence of clinical activity in a MET biomarker selected expansion cohort. Secondary objectives of the study include determination of pharmacokinetic (PK) characteristics, and indication of biological activity and clinical efficacy at doses and schedules at or below the maximum tolerated dose (MTD) or maximum feasible dose (MFD). The first patient in this Phase I/II clinical study was dosed in August OMO-2 is a differentiated follow-up MET-inhibitor with similar high selectivity that is in late non-clinical development and IND enabling tox studies have recently been initiated with clinical studies projected to start in 1Q Phospho MET protein (red) in untreated H1993 lung cancer cells. Counterstained for DNA (blue). MET protein (green) in OMO treated H1993 lung cancer cells. Counterstained for DNA (blue). 3

4 Team Timothy Perera, PHD, CEO Tim has more than 25 years global pharma experience in drug development. Before setting up OCTIMET he was Global Discovery Leader Lung Disease Area at J&J. He has led 4 discovery projects that reached clinical stage. Ann Meulemans, PhD, CDO Ann has more than 25 years experience in discovery, product development and product strategy in big pharma (JNJ and Shire) and small biotech (Movetis). She brought more than 5 drugs in different indications from lead identification to POC in man. Prof Glen Clack, MD, FFPM, CMO Glen has 20 years experience in oncology drug development and translational medicine. Before joining OCTIMET, Glen has held the position of senior medical director at AstraZeneca. He holds various honorary academic positions and is a member of the oncology innovative medicines group. Prof Paolo Comoglio, MD, PhD, Scientific Advisor Paolo has more than 25 years experience with MET biology resulting in more than 300 publications. He was the Scientific Director of the Candiolo Cancer Institute IRCCS in Turin, Italy and is currently the Dean. Prof Comoglio was one of the founding scientists of the MET biology field. Philip Owen, FCA, CFO Philip is an executive finance leader in both big and small companies with over 25 years experience. He is a qualified chartered accountant, tax adviser and corporate treasurer. Marion Libouban, PhD, Principal Scientist Marion studied in France, Italy, UK, Germany and the Netherlands as well as having 2 years experience in biotech drug development where she managed external collaborations with academia and CRO s. Marion has a strong background in the application of molecular biology, immunology and in vivo model development to Oncology. Eric Ciamporcero PhD Senior Scientist Eric has 10 years experience in oncology, resulting in more than 20 publications. Trained in Italy as a molecular biologist, he then worked in a translational research lab in the USA, where he conducted, in vivo studies to assess efficacy of MET inhibitors. Eric joined OCTIMET after two years at J&J where, as postodoctoral scientist, he led target identification efforts. Debbie Van Beylen, Office Manager, Project Planner Debbie has more than 12 years experience in office management and more than 5 years experience with clinical research. 4

5 Why JLINX Access to Janssen s high-level expertise thought the implantation of OCTIMET s activities at the Janssen Beerse campus is crucial to accelerate the further development plans. Although initial activities were started in Oxford, the opportunity to operate in a dynamic entrepreneurial community at the heart of the largest R&D ecosystem in Europe, has driven OCTIMET to take residence at the JLINX facility in Beerse that is managed by Bioqube Ventures. Cross-fertilization and smooth, organic exchange of knowledge with oncology experts and multi-disciplinary life science entrepreneurs within the JLINX community fuel a new model of scientific collaboration offering OCTIMET faster access to expertise and cross-sector insights that do not typically reside in small, start-up companies. Advisors & Partners Highlights 2014 Development OCTIMET business plan during Janssen Boot camp 2015 Early start of activities in Oxford 2016 Registration as OCTIMET NV 2016 Formal launch OCTIMET as JLINX resident 2016 Grant from Flanders Innovation & Entrepreneurship (VLAIO) and Seed Capital from the VIB (Vlaams Instituut voor Biotechnologie) 2017 Series A Funding led by V-Bio Ventures and Fund+ and supported by an investment syndicate incl. DROIA Oncology Ventures and OMNES Capital Start OMO-1 Phase I Clinical Study Future 2018 Top line results OMO-1 Phase I Clinical Study expected 2019 Start OMO-2 Pre-clinical Study

6 Contact OCTIMET Oncology NV Timothy Perera phone: Headquarters: OCTIMET Oncology NV Oudepostelseweg Geel, Belgium supported by: